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RELENZA
Overview
What is RELENZA?
The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)-4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of CHNOand a molecular weight of 332.3. It has the following structural formula:
Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg/mL in water at 20°C.
RELENZA is for administration to the respiratory tract by oral inhalation only. Each RELENZA ROTADISK contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose (which contains milk proteins). The contents of each blister are inhaled using a specially designed breath-activated plastic device for inhaling powder called the DISKHALER. After a RELENZA ROTADISK is loaded into the DISKHALER, a blister that contains medication is pierced and the zanamivir is dispersed into the air stream created when the patient inhales through the mouthpiece. The amount of drug delivered to the respiratory tract will depend on patient factors such as inspiratory flow. Under standardized in vitro testing, RELENZA ROTADISK delivers 4 mg of zanamivir from the DISKHALER device when tested at a pressure drop of 3 kPa (corresponding to a flow rate of about 62 to 65 L/min) for 3 seconds.
What does RELENZA look like?
What are the available doses of RELENZA?
Blister for oral inhalation: 5 mg. Four 5 mg blisters of powder on a ROTADISK for oral inhalation via DISKHALER. Packaged in carton containing 5 ROTADISKs (total of 10 doses) and 1 DISKHALER inhalation device. (3)
What should I talk to my health care provider before I take RELENZA?
How should I use RELENZA?
RELENZA (zanamivir) Inhalation Powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than 2 days.
What interacts with RELENZA?
Sorry No Records found
What are the warnings of RELENZA?
Sorry No Records found
What are the precautions of RELENZA?
Sorry No Records found
What are the side effects of RELENZA?
Sorry No records found
What should I look out for while using RELENZA?
Do not use in patients with history of allergic reaction to any ingredient of RELENZA including lactose (which contains milk proteins).
What might happen if I take too much RELENZA?
There have been no reports of overdosage from administration of RELENZA.
How should I store and handle RELENZA?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature). RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device.They are supplied by as follows:This product was Manufactured By: GlaxoSmithKlineAnd Relabeled By:Dispensing Solutions Inc.Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) (see USP Controlled Room Temperature).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Zanamivir is an antiviral drug .
Non-Clinical Toxicology
Do not use in patients with history of allergic reaction to any ingredient of RELENZA including lactose (which contains milk proteins).SINGULAIR has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug-interaction studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1 mg/ethinyl estradiol 35 mcg), terfenadine, digoxin, and warfarin.
Although additional specific interaction studies were not performed, SINGULAIR was used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions. These medications included thyroid hormones, sedative hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, and decongestants.
Phenobarbital, which induces hepatic metabolism, decreased the AUC of montelukast approximately 40% following a single 10-mg dose of montelukast. No dosage adjustment for SINGULAIR is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P450 enzyme inducers, such as phenobarbital or rifampin, are co-administered with SINGULAIR.
RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease).
Serious cases of bronchospasm, including fatalities, have been reported during treatment with RELENZA in patients with and without underlying airways disease. Many of these cases were reported during postmarketing and causality was difficult to assess.
RELENZA should be discontinued in any patient who develops bronchospasm or decline in respiratory function; immediate treatment and hospitalization may be required.
Some patients without prior pulmonary disease may also have respiratory abnormalities from acute respiratory infection that could resemble adverse drug reactions or increase patient vulnerability to adverse drug reactions.
Bronchospasm was documented following administration of zanamivir in 1 of 13 patients with mild or moderate asthma (but without acute influenza-like illness) in a Phase I study. In a Phase III study in patients with acute influenza-like illness superimposed on underlying asthma or chronic obstructive pulmonary disease, 10% (24 of 244) of patients on zanamivir and 9% (22 of 237) on placebo experienced a greater than 20% decline in FEV following treatment for 5 days.
If use of RELENZA is considered for a patient with underlying airways disease, the potential risks and benefits should be carefully weighed. If a decision is made to prescribe RELENZA for such a patient, this should be done only under conditions of careful monitoring of respiratory function, close observation, and appropriate supportive care including availability of fast-acting bronchodilators.
See Warnings and Precautions for information about risk of serious adverse events such as bronchospasm (5.1) and allergic-like reactions (5.2), and for safety information in patients with underlying airways disease (5.1).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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